What You Need to Know:

Results of a phase 2 study found ridinilazole, an antimicrobial agent that acts specifically in the gastrointestinal tract, to be non-inferior to vancomycin in the treatment of Clostridium difficile infections.

Trial Design:

Double-blind, active-controlled, non-inferiority phase 2 study compared the safety and efficacy of ridinilazole to vancomycin in patients with “signs and symptoms of C. difficile infection and a positive diagnostic test result”

Primary endpoint: “achievement of a sustained clinical response, defined as clinical cure at the end of treatment and no recurrence within 30 days, which was used to establish non-inferiority (15% margin) of ridinilazole versus vancomycin”

Efficacy analysis was conducted in a modified intention-to-treat population, which included all patients with a confirmed C difficile infection who received at least 1 dose of study drug)

Key Outcomes:

Primary efficacy analysis: included 36 patients in the ridinilazole group and 33 patients in the vancomycin group